Silk'n Flash & Go Pro
Silk'n Flash & Go Pro (7290016627121) is a cosmetic red-light phototherapy system (FDA Class II) made by Home Skinovations, Ltd., cleared under FDA 510(k) K141242 on 17 Oct 2014 and listed in FDA GUDID since 25 Jan 2018 (UDI-DI 17290016627128), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number17290016627128 | Date25 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141242 | Date17 Oct 2014 | StatusActive |
Official records
- AccessGUDID record 17290016627128
- FDA 510(k) database K141242
Across registries
- FDA 510(k) K141242 decided 17 Oct 2014 Active
- FDA GUDID UDI-DI 17290016627128 listed 25 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K141242
- Listed FDA GUDID 17290016627128
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Silk'n
- Generic name
- Cosmetic red-light phototherapy system, home-use
- Model / Ref / Catalog
- Flash & Go Pro, 7290016627121
- Primary DI / UDI-DI
- 17290016627128
- 510(k) Number
- FDA product code
- ONF, OHT
- GMDN term
- Cosmetic red-light phototherapy system, home-use
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).
- Magma Spark Pro FS90000 by FORMATK SYSTEMS LTD
- Harmony Lite System 110V For Alma Inc (purple) AASP12121105 by ALMA LASERS LTD.
- Isolaz 2 Intense Pulsed Light System by Solta Medical, Inc.
- Mini Me by Iluminage Ltd.(Formerly Syneron Beauty Ltd.)
- IPL Hair Removal Device KCA423 by Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.
- Shaser HRS2 RX Hair Removal System by Shaser, Inc.
- Lucent : IPL by Luvo Medical Technologies Inc
- F-SR FS10004 by FORMATK SYSTEMS LTD
- Shaser V-Mini RX by Shaser, Inc.
- Ellipse I2PL+/ELLIPSE MultiFlex+ by Ellipse A/S